Loading...
Current asthma guidelines recommend adding a long-acting beta-agonist (LABA) for children whose asthma is not controlled with low- to medium-dose inhaled corticosteroids (ICSs). However, there is evidence that LABAs increase the risk for asthma-related deaths in adults, and it is unclear if concomitant use of an ICS mitigates this risk. The FDA asked the manufacturer to conduct large studies to assess the safety of salmeterol when used with fluticasone in a fixed-dose combination device (Advair Diskus).
In an international trial, 6208 children aged 4 to 11 years with asthma and an exacerbation in the previous year were randomized to salmeterol or placebo plus twice-daily inhaled fluticasone (100 or 250 µg, depending on asthma severity) for 2…